to trainees. Training for all junior faculty trainees will consist of both didactic and mentored research training as well as additional opportunities provided through the K12-MCTRS program such as special seminars and colloquiums and other activitiesdescribed below. The length of training within the ACTSI K12-MCTRSprogram will be limited to two or three years, depending on progress and trainee needs, to ensure that trainees maintain K23 (or K08) eligibility. This will also enable us to train a larger number of trainees and ensure that trainees aggressively pursue external funding to continue to support their own career development. We will continue to require that alltrainees submit a K23 or K08 grant (or other federal grant such as an R01, as appropriate) within 1year of beginning the program. 01a. Didactic Research Training. The core component of didactic research training for K12-MCTRS trainees will be through the MSCR program. All candidates accepted into the K12 program will be enrolled in and complete the MSCR graduate degree program at Emory or MSM. The first year of the K12 program will be focused primarily on didactic training with additional time spent on mentored research training while the second (and third year if applicable) is focused on mentored research training. Electives. K12-MCTRS trainees may need to move beyondthe core requirements of the MSCRdegree program, depending on their research project, interests and career goals. The second year of the K12 program is focused on mentored research training but also provides the opportunity for trainees to take elective courses as described above for the MSCR program. The list of elective courses is shown in Table 4. Other Didactic Training. The K12-MCTRS program will provide additional support through ongoing functions such as ajoint Emory-MSM-GA Tech journal club for K12 trainees and other trainees in the MSCR programs at Emory and MSM, colloquiums and special seminars. The importance of multidisciplinary and interdisciplinary research will be emphasized in these additional colloquiums and seminars held in collaboration with the Emory and MSM MSCR programs. Other didactic training needed for aspecific participant will be determined in consultation with the trainee's Lead Mentor and the Program Director. In lieu of the MSCR degree program, trainees could pursue other graduate degrees (e.g., Ph.D. in Epidemiology or Biostatistics) but the MSCR core curriculum courses must be incorporated into that graduate degree program. K12-MCTRS Colloquium. The K12-MCTRS Colloquium will be a special seminar series forK12-MCTRS trainees (and open to others in the MSCR program). The purpose is to provide trainees with additional exposure to multidisciplinary team approaches to CTR as well as a forum for trainees to present their research to other trainees at Emory, GA Tech and MSM. Investigators at the CIN and Pis of center or program grants at Emory, MSM, and GA Tech, along with directors of selected T32 training programs, and key leaders at the collaborating Atlanta institutions will present a series of seminars on their CTR careers and how they have organized multidisciplinary teams to address complex issues in biomedical research. Invited speakers from outside institutions will be included and there will be an emphasis on successful inter-institutional research teams. Current and previous K12-trainees will also be invited to present their research in this forum. D1b. Mentored Clinical and Translational Research Training. All K12-MCTRS trainees will have clinical and/or translational research training under the direction of their Lead Mentor. An investigator initiated, hypothesis driven research proposal with specific aims will be developed by each trainee and initially outlined in the application submitted by candidates applying for the K12 program. Progress towards those aims will be updated in written semi-annual reports and in semi-annual meetings of the K12 trainee, their Lead Mentorand the RETCD Program Director and Co-Program Director. Mentored research will begin during the first year of the program and most of the second year of the K12*-MCTRS program (and third year if applicable) time will be devoted to working on their CTR project under guidance of the lead mentor and mentoring team. PHS 398/2590 (Rev. 09/04,Reissued 4/2006) Page 646 Continuation Format Page Principal Investigator/Program Director (Last, First, Middle): Stephens, David Mentoring. Having committed and successful clinical investigators who serve as Lead Mentors for trainees is a key element of the proposed K12-MCTRS program. All Lead Mentors for our K12 program will be required to be NIH-funded investigators. The importance of mentorship training for Lead Mentors of trainees in our K12 and K30-MSCR programs has been recognized and increasingly emphasized over the past few years. All K12 mentors and trainees will attend an orientation session to clarify the program's expectations and the responsibilities of the Lead Mentor and the trainees. All K12trainees must have a formal Mentorship Team consisting of the Lead Mentor, a biostatistician or expert in bioinformatics, and 1to 3 additional co-mentors based on the needs of the trainee and their area of research. Trainees at each institution will be encouraged to have 1 co-mentor from a collaborating institution (Emory, MSMor GA Tech). A trainee pursuing translational research focused on bench to bedside transtational researchwould also have a mentoring team member with expertise in clinical research and/or translation from bedside to community. Those working on clinically- focused projects would have a team member engaged in bench-to-bedside translational research. The goal is to broaden the trainees'research vision and affirm the Importance of multidisciplinary approachestocomplex research issues. We will encourage teams to include a mid-level faculty member as a co-mentor to increase the number of faculty with CTR mentorship experience. Potential Lead Mentors. A major strength of the proposed K12 program is the academic strength and breadth of potential lead mentors from Emory, MSM and GA Tech. Based on the model of our current K12 program, the lead mentor must be an established and successful clinical investigator as demonstrated by active NIH funding. The mentor pool includes hundreds well-qualified clinical and translational investigators at Emory, GATech, and MSMwho constitute the potential mentor pool. A representative sample of potential lead mentors is listed below in Table 7. This includes ACTS! program directors and co-program directors (whose biosketches are included as key ACTS! participants) as well as 30 other potential mentors from Emory, GATech, and MSM (NIH biosketches of these individuals are also included in the application). D2. Flexibility of the K12-MCTRS Program The K12-MCTRS structure will be flexible to allow trainees to become well-trained, ethical and independent researchers able to conceptualize and conduct cutting edge CTR. Program flexibility is necessaryto accommodate candidates with varying levels of research experience accepted into the program and to accommodate the needs of trainees with different backgrounds (e.g., physician-scientist and PhD scientist junior faculty). Each trainee's training program will be individualized in consultation with their Lead Mentor and the K12-Program Director. The K12-MCTRS programwill accept candidates with varying backgroundsand research experience. Based on their needs and research interests, some candidates will require additional electives while others may pursue a limited number of electives outside of the core MSCR program. The K12- MCTRS program will provide candidates with two-to-three years of support based on progress and need. D3. Applicant Pool and Selection of Candidates: A large applicant pool of talented and committed junior faculty applicants with outstanding potential to become successful clinical investigators exists for the proposed K12-MCTRS program. The pool of K12 candidates will be drawn from junior faculty at the Emory University School of Medicine (n=1249), Emory RSPH (n=45), Emory SON (n=10), GATech BME or Bioengineering (n=28), and MSM(n=151). D3a. Number of Trainees The number of ACTSI-supported K12 trainees will be increased to a total of 10 K12-MCTRS positions per year from the current funding for 6-7 trainees per year provided by the current NCRR K12 award. This will enable ACTSI K12 program to include support for PhDjunior faculty in addition to MD and MD/PhDjunior faculty at Emory as well as GA Tech and MSM. A minimum of two K12 positions per year will be allocated to qualified MSMjunior faculty. Additional MSM trainees could also be funded through the competitive process as described below. [unreadable] - - D3b. Application Process. Candidates are required to identify a Lead Mentor who is a faculty member at one of the collaborating institutions and an established and successful investigator in CTR. Junior faculty applicants will be required to submit an application to the K12 program that includes a maximum 15-page proposal incorporating a research training program (statement on career goals, the plan for didactic training, interactions with Lead Mentor and mentoring team), and a hypothesis-driven clinical and/or translational research proposal to be carried out over the two to three years of support. All trainees are required to PHS 398/2590 (Rev. 09/04, Reissued 4/2006) Page 647 Continuation Format Page e a S, [unreadable] [unreadable] e o cn a. [unreadable] c o u IOCinO ffi 1 .8 1 ro Q of n 0) ^S ex 0) CO I JB [unreadable]o o> T> .[unreadable] il 1 v 5 5> 5 n | = s, Q n Q. ID G 8s co a I P D i co ED 8 O 0) [unreadable] (0 il 3 M (Q > 5 [unreadable] 0)S [unreadable]c U) to 8 m CO if ZII K^rf :X Q = g (0 [unreadable]2-2 [unreadable]\* ? 5 Qi Uto k[unreadable] i- S 'B > |*Q[unreadable][unreadable]w .1 CQ >^ I* V) <2 CLK (0 <QQ. Q. Principal Investigator/Program Director (Last, First, Middle): Stephens, David complete the MSCR didactic training program. NIH style biosketches from the candidate, their lead mentor and members of the multidisciplinary mentoring team are included in the application and letters of support from the lead mentor and mentoring team are required. The candidate is also required to submit a letter of support from their Department Chair guaranteeing the requisite protected time (75-90% except for those in the surgical specialties who may devote 50% effort) outlined in the budget if the candidate is accepted into the program and a letter of support from their Lead Mentor. Candidates for the K12 program must also: 1) be a full time junior faculty member at Emory, MSM or GA Tech (Instructor or Assistant Professor level) at the time of receipt of the award [MD, MD/PhD and PhDfaculty];2) agree in writing to serve at least one year on the faculty at an academic institution pursuing CTR for each year of support provided by the K12 program (the goal would be for the trainees to spend a career in clinical investigation but this pledge would emphasize the importance of identifying persons interested in pursuing a career as a clinical and/or translational researcher);3) be a U.S. citizen or permanent resident and meet all other NIH eligibility criteria;4) Agree to abide by the rules and regulations of the K12 Program (e.g., submit a K23 application within 1 year of entering the program, provide semi-annual written progress reports, meet with the Program/co-Program Director every 6 months to discuss progress in the program, agree to provide the Program Director with annual updated information following completion of the program on career progress, academic position, publications, funding, etc.). D3c. Selection Process Applications to the K12 program will be reviewed by a K12 special study section that consists of faculty members from Emory, GA Tech, and MSMwho serve on the RETCD Executive Committee. RETCD Advisory Committee as well as ad hoc members with expertise in the specific areas of submitted applications. For each application, there will be two primary reviewers. Rules to assure there is no conflict of interest have also been developed so that reviewers will not participate in reviews of applications where they may be a mentor or for applicants from their department (or division if the Department of Medicine). Selection criteria are established in advance by the Advisory Committee and include: 1) potential of the candidate to develop into a successful and independent clinical investigator;2) evidence of commitment on part of the applicant's Lead Mentor, mentoring team and the experience and success of the Lead Mentor in mentoring trainees;3) the quality of the proposed research project and development plan;and 4) diversity issues (to encourage training of candidates from different departments, of different genders and from underrepresented minority groups). Each applicant's evaluation will be scored by study section members using a NIH style scale (1.6 to 5.0). Applicants will be ranked on the basis of this score arid offered a position based on rank and availability of training slots. Written evaluations by the reviewers and summary of the discussion of the study section will be provided to all applicants. Promising applicants who are not initially funded will be placed on a waiting list on the basis of their priority score and encouraged to re-apply the following year. These individuals could also be admitted into the program during the year to fill an open position if a current K12-MCTRS trainee received external funding (e.g., K23) and graduated from the program. D4. Certifications: All K12 trainees will be required to obtain at a minimum: 1) the MSCR degree within two years of entry into the program. 2) Human Subjects Research Training -this will be accomplished as described above for the MSCR program and includes an Ethics course, a Values in Science Workshop presented by the Emory Center for Ethics and completion of the Emory IRB Human Subjects Education Program (www.emorv.edu/IRB)online course;3) CIN training as described above for MSCR participants; 4) Submission of a grant application for external funding within oneyear of entrance into the K12 program: For the large majority of trainees this includes a K23 (or K08) application;if more appropriate a R01 or other application may be submitted. D5. Evaluation and Benchmarks. K12 program evaluation is an essential component of ACTS! activities. Improvements and revisions to the K12 program will be made by the RECTD Executive Committee based on results of the evaluation by the Lead Evaluator and evaluation team (incorporating feedback from trainees and their mentors) as well as input from the RECTD Advisory Committee. Evaluation metrics include the number of applicants to the K12-MCTRS Program, the quality of the applicants (e.g., based on the review of their research plan), the number of applicants accepted each year, as well as the diversity of applicants who apply and who are accepted (including number of minority candidates and women). Metrics to be followed will include scholarly activities including number of peer-reviewed publications by each trainee;number of .presentations at scientific meetings;grant proposals submitted and funded;types of grant funding;multidisciplinary research;mentoring . PHS 398/2590 (Rev. 09/04, Reissued 4/2006) Page 652 Continuation Format Page Principal Investigator/ProgramDirector (Last, First, Middle): Stephens, David of medical students, housestaffand other trainees;awards;and career trajectory. The RETCD Executive Committee and Advisory Committee will assess programprogress, review evaluations and make changesas necessary to meet the goals and objectives of the program. We will continue to track the careers of the former K12 trainees and provide forums for discussion offurther career development issues including R01 applications, multidisciplinary and interdisciplinary research including participation, and leadership of sections of program project grants. The following information that will be collected on an annual basis will include: scholarly activities (including scientific presentations, publications in peer-reviewed journals);research grants and contracts received;sponsor, type and amount of the award; academic appointments, type of career, percent of effort spent on patient-oriented clinical research;students, housestaff or faculty members they have mentored on a clinical/translational research related project;other training which they believe would be of benefit to include in the K12-MCTRS Program. The following benchmarks will be established for the K12-MCTRS Program and we will monitorwhether these benchmarks are being met: . [unreadable] Retention rate of >90% of the applicants admitted into the program (minimum of 2 years of training). [unreadable] 100% completion of the Emory IRB Human Subjects Education Program by trainees within one month of acceptance into the K12 Program. [unreadable] 100% completion rate of the MSCR program (course work, mentored thesis). [unreadable] 100% graduation rate with MSCR degree (excluding a limited number of participants who would be pursuing other graduate degrees such as a PhD). [unreadable] >75% of the participants will besuccessful In obtaining external-funding to support further career development and CTR(e.g., K23, K08, foundation career development award, or other type of federal funding) before the end of 2 or 3 years of funding through the K12program. Such participants would graduate from the program upon receipt of external funding opening their slot for a new trainee to receive K12 support. [unreadable] >90% of the trainees will be successful in obtaining external funding to support CTR within five years of entering the program. Reports by K12 Trainees and Mentors. Written semi-annual reports must submitted by all junior faculty trainees and an additional annual report by their lead mentor. The K12 trainee's report must summarize activities over the 6 months, progress made in the MSCR program, MSCR mentored thesis required for . graduation, accomplishments, any changes regarding academic appointment, awards related to scholarly activity, publications, and research grants and contracts applied for and received. 'Along with their Lead Mentor, trainees will meet with K12 Program Director and co-Program Director on an every 6 month basis to review the report and discuss progress made. Trainees must also submit plans for the coming year and how they will allocate the technical budget funds ($25,000) for tuition support, research supplies and support, etc. IV.Advanced Certificate Program In CTRand Intensive Short Course Training Program Specific Aim 3. To enhance the research environment in Atlanta and establish opportunities for CTR training in a wider and more diverse group of trainees and investigators by establishing medium term training (advanced certificate program In CTR) andintensive short course programs. A. Advanced Certificate Program in Clinical and Translational Research (CTR) The development of the certificate program addressesthe needs of a wide variety of potential trainees who will be part of multidisciplinary research teams and desire and would benefit from CTR training (see Table 1). The development of this program fills a gap between the extensive and in-depth didactic and mentored research training provided through the MSCR degree program and 1-2 hour lectures and 1-2 day workshops provided by the Office of Human Studies Research (OHSR) which has focused on educational activities for study coordinators. The target audience for the AdvancedCertificate Program includes PhD graduate students, postdoctoral fellows, and selected faculty at the partnering institutions, metropolitan Atlanta community physicians involved in clinical research, housestaff physicians (residents and fellows at Emory and MSM),and research nurse leaders. A minimum of 12credit hours Is required for the certificate, which willbe awarded as a formal certificate by the Emory University Graduate School of Arts and Sciences or by MSM. PHS 398/2590(Rev. 09/04, Reissued 4/2006) Page 653 Continuation Format Page